Data / Medical devices / United States / Reazeal Corp
Reazeal Corp: FDA-registered device maker in Wilmington, DE, United States, 2 510(k) clearances
Reazeal Corp is registered with the FDA (registration 3028271666) in Wilmington, DE, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 3, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3028271666
- Address
- 1226North King St. #485, Wilmington, DE, United States, 19801
- Owner or operator
- REAZEAL CORP (10090157)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 22, 2024
- Registered through
- 2026
- Brand names listed
- Mouth Guard, Mouth Guard for Grinding Teeth, REAZEAL ANTI SNORE MOUTHPIECE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 2 | Manufacturer | accessdata.fda.gov |
| Mouthguard, Over-The-Counter | OBR | U | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 3, 2025 | K250028 | Anti Snore Mouthpiece | LRK | Substantially Equivalent | Dongguan Yiyao Science & Technology Development Co., Ltd. | accessdata.fda.gov |
| November 6, 2023 | K231865 | Mouth Guard (ATG0603R) | OBR | Substantially Equivalent | Reazeal Corp | accessdata.fda.gov |
Compare with other makers
Updated October 3, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.